Z-0076-2019Class II

BioFlo Port with ENDEXO and PASV Technology-AngioDynamics BIOFLO 8F SINGLE PLASTIC NON-FILLED; VALVED PG UPN...

Name: Z-0076-2019 BioFlo Port with ENDEXO and PASV Technology-AngioDynamics BIOFLO 8F SINGLE PLASTIC NON-FILLED; VALVED PG UPN...
Creator: Angiodynamics Inc. (Navilyst Medical Inc.)
Published: 2018-07-24
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2018-07-24 / Terminated / root cause: sterility

FDA source

Angiodynamics Inc. (Navilyst Medical Inc.) began a recall of BioFlo Port with ENDEXO and PASV Technology-AngioDynamics BIOFLO 8F SINGLE PLASTIC NON-FILLED; VALVED PG UPN: H965440210 Catalog Number: 44-021 Box of 1 Port -... on 2018-07-24. FDA classified it as Class II and gives the reason as "BioFlo Ports was partially manufactured with the incorrect sterile port assembly. The actual sterile port assembly used was, 8F SL Xcela Plus Titanium Valved Non-Filled, when it should have been, 8F SL BioFlo Plastic...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-0076-2019
Classification: Class II
Status: Terminated
Initiated: 2018-07-24
Posted: 2018-10-05
Terminated: 2019-05-17
Recalling firm: Boston Scientific Corporation
Product: BioFlo Port with ENDEXO and PASV Technology-AngioDynamics BIOFLO 8F SINGLE PLASTIC NON-FILLED; VALVED PG UPN: H965440210 Catalog Number: 44-021 Box of 1 Port - Product Usage - Long-term access to the central venous system for administration of fluids including but not limited to hydration fluids, chemotherapy, analgesics, nutritional therapy and blood products. The device is also indicated for blood specimen withdrawal.
Product code: LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
Reason for recall: BioFlo Ports was partially manufactured with the incorrect sterile port assembly. The actual sterile port assembly used was, 8F SL Xcela Plus Titanium Valved Non-Filled, when it should have been, 8F SL BioFlo Plastic Valved Non-Filled
Root cause tag: sterility
FDA root cause: Unknown/Undetermined by firm
Action: On July 24, 2018 AngioDynamics initiated this recall action by notifying the affected consignee via telephone call.Per the telephone conversation, the consignee was instructed to segregate the affected device and quarantine the product until further direction from AngioDynamics. A follow-up letter issued dated 7/24/18 email response form to be completed and returned.
Quantity in commerce: 1 box
Distribution: US Nationwide in the state of IN.
Product codes and lots: Lot Number: 5363172

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0076-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0076-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-17	2018-10-05

Product code LJT

K131694Class IINmi Port II CatheterNavilyst Medical, Inc. / cleared 2013-08-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)